Salter Labs 8350-1 AIRE Elite Compressor Nebulizer User Manual

Salter Labs 8350-1 AIRE Elite Compressor Nebulizer User Manual

Thank you for selecting the Salter AIRE Elite Compressor. Salter Labs is an innovative, industry-leading manufacturer of respiratory care devices. Please contact your local Salter Labs dealer for information about additional products.

Important Safeguards
NOTE, CAUTION, WARNING, AND SYMBOLS: Important information is highlighted by using the following:
NOTE Indicates information that the user should pay special attention to.
CAUTION Indicates correct operating or maintenance procedures to prevent damage to or destruction of the equipment or other property.
WARNING Indicates potential danger that requires correct procedures or practices to prevent personal injury.

Symbols

• Off, disconnection from the mains
• On, connection to the mains
• Alternating Current (AC)
• IP2X is Protected against solid foreign objects having a diameter of 12.5 mm and greater. No protection against vertically falling water drops. Keep dry!
• Attention
• Class II
• Refer to the struction manual/ booklet
• “The F” symbol, indicates this product is according to the degree of protection against electric shock for the type BF equipment.
• Temperature limitation
• Disposal of Electrical & Electronic Equipment (WEEE): This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment.
• For more detailed information about the recycling of this product, please contact your local city office, household waste disposal service or the retail store where you purchased this product.

CAUTION U.S. Federal Law restricts this device to sale by or on the order of a physician.
WARNING To reduce the risk of burns, electrocution, fire or injury to persons:

1. Always unplug this product immediately after using it.
2.  Do not use it while bathing, showering, dishwashing, or close to water sources of any kind.
3. Do not place or store product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into the water. Unplug immediately.
6. This product should never be left unattended when plugged in.
7. Close supervision is necessary when this product is used by, on or near children or invalids. The choking accident may result from a child swallowing a small part that has become detached from the device or its accessories.
8. Use this product only for its intended use as described in this manual. Use this product only under the doctor’s direction. Do not use attachments not recommended by the manufacturer.
9. Never operate this product if a) it has a damaged cord or plug, b) it is not working properly, c) it has been dropped or damaged, and d) it has been dropped into water.
10. Return the product to a specified service centre for examination and repair.
11. Keep the cord away from heated surfaces.
12. Never block the air openings of this product or allow objects to fall or be inserted into the air vent openings or place it on a soft surface such as a bed or couch, where the air openings may be blocked.
13. Never use it while sleeping or feeling drowsy.
14. Never drop or insert any object into any opening or hose.
15. No modification of this equipment is allowed.
16. Do not modify this equipment without the authorization of the manufacturer.
17. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.
18. Do not use in outdoors or operate where aerosol (spray) products are being used or where oxygen is being administered in a closed environment such as an oxygen reservoir.
19. Do not wrap the power cord around the compressor (main unit).
20. Disconnect the power plug by pulling the plug, not by pulling on the compressor (main unit), or the cord.
21. If the power cord or plug becomes frayed or otherwise damaged, do not use it.
22. Do not place heavy objects on the power cord, or bend and pull the cord harder than necessary. These actions could cause an electric shock or fire.
23. Potential allergic reactions to accessible materials used in the Compressor Nebulizer equipment. If any signs of allergic reaction or hypersensitivity happen, stop the treatment immediately, and notify the doctor or nurse.
24. Potential contact injuries for patients used in the Compressor Nebulizer equipment. If any contact injuries happen, stop the treatment, and notify the doctor or nurse.
25. The device enclosure may overheat, users do not touch more than 10 seconds.

WARNING EMC Statement
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1:2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used by the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment to an outlet on a circuit different from that to which the other device(s) are connected.
• Consult the manufacturer or field service technician for help.

CAUTION
If there is a possibility of electromagnetic interference with mobile phones, please increase the distance (3.3m) between devices or turn off the mobile phone.

Introduction

Intended Use
The Salter AIRE Elite Compressor System is intended to provide a source of compressed air for aerosol therapy. It is used in conjunction with a jet (pneumatic) nebulizer to produce medicated aerosols for inhalation by pediatric and
adult patients with respiratory symptoms.

CAUTION
Aerosolize liquid medication except Pentamidine for inhalation by the patients. Indications for therapy include asthma, chronic bronchitis, infection of the upper respiratory tract, chronic obstructive pulmonary disease (COPD) and other respiratory disorders by a medical doctor’s prescription. Except for the usage mentioned above, please do not use this product for any other purpose. This device can be used with adults or pediatric patients under a physician’s prescription.

Safety Precaution Instruction
When using this electrical product, especially when children are present, one should always follow basic safety precautions. Do not install, maintain or operate this equipment without reading, understanding and following the proper Salter AIRE Elite Compressor System instruction manual, otherwise injury or damage may result. For 120V only- This appliance has a polarized plug (one blade is wider than the other). To reduce the risk of electric shock, this plug is intended to fit into a polarized outlet only one way. If the plug does not fit fully into the outlet, reverse the plug. If it still does not fit, contact a qualified electrician. Do not modify the plug in any way.

Product Description

1. Power Switch
2. Filter Cap (disposable filter inside)
3. Air-Outlet Connector
4. Integrated Carrying Handle
5. Power Cord
6. Nebulizer Cup Holder
7. Cooling Air Openings

Operation

NOTE Before initial operation, the nebulizer cup assembly should be cleaned following the instructions described in the “Cleaning” section.
WARNING Before connecting the power cord, make sure the I/O (ON/OFF) switch is in the O (OFF) position. The plug is also served to disconnect the device. Do not position the equipment so that it is difficult to operate the disconnecting device.

Daily Use Operation
CAUTION The Salter AIRE Elite Compressor System is designed for intermittent use only. Do not operate it continuously for more than 30 minutes for a single use without turning it off and following a cooling period for at least 30 minutes.

1. Before each use inspect the Salter AIRE Elite Compressor and nebulizer cup assembly for damage or wear, and replace as needed.
2. Place the Salter AIRE Elite Compressor on a table or other flat stable surface. Be sure you can easily reach the controls when seated. Do not use this device on the floor.
3. With the power switch in the O (OFF) position, plug the power cord into an appropriate electrical wall outlet.
4. Connect one end of the tubing to the compressor air-outlet connector.
5. Assemble the nebulizer cup and add the indicated medication to the nebulizer’s cup before use.
6. Attach the other end of the tubing to the air-inlet connector found at the bottom of the nebulizer cup.
7. Turn on the Salter AIRE Elite Compressor by pressing the power switch to the I (ON) position and begin treatment.
8. If treatment needs to be interrupted, simply press the power switch to the O (OFF) position.
9. When the treatment is complete, turn off the compressor by pressing the power switch to the O (OFF) position and unplug the unit from the electrical outlet.
10. Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. This device has no AP or APG protection.
    CAUTION During the treatment, the patient should not touch the outer case due to the expected rise in unit temperature.

Safety Overload
NOTE Do not exceed 30 minutes of continuous operation.

1. The motor of this device has a built-in thermal overload protector. Should the motor overheat, the protector will automatically shut off the motor. Should this occur, turn the I/O (ON/OFF) switch to the O (OFF) position and allow the motor to cool down for approximately 30 minutes before turning it on again.
2. If the overload protector shuts off the motor frequently, you may have an unstable voltage situation.
3. If the unit shuts down and cannot restart, it may need to be replaced. Call your provider immediately.

Cleaning
Compressor Outer Case Cleaning
WARNING Electric shock hazard. Do not remove the outer case of this unit. All disassembly and maintenance of this unit must be done by a qualified service technician. Refer servicing to qualified service personnel.

WARNING This unit does not require oil. Do not attempt to lubricate any internal parts.
WARNING Unplug the nit before cleaning. Do not submerge in water for cleaning.

1. Wipe the main unit with a damp cloth every few days to keep it dust-free.
2. Do not use any powdered type cleaners or soap. Do not submerge the unit in water.

Nebulizer Cup Cleaning
Clean the nebulizer after each use. Refer to the cleaning instructions supplied with your nebulizer

WARNING To prevent possible risk of infection from contaminated medication, cleaning the nebulizer is recommended after each treatment.
NOTE The nebulizer kit is for single patient use only.
NOTE Please follow national requirements to dispose of the unit properly.

Storage

Keep the unit and accessories dry. Avoid direct sunshine. See specifications in Section 10 for appropriate environmental storage conditions.

Maintenance

General Information

1. This unit is oil-less. Do Not Lubricate.
2. Risk of electric shock. Do not disassemble the main unit.

Filter Change
NOTE Inspect the filter once every month and replace it as necessary or when the filter turns grey. Please follow the below instructions as the right figures.

1. Open the filter cap.
2. Inspect the filter and if dirty, remove the filter with a small, pointed object.
3. Discard the filter.
4. Replace with a clean filter. Additional filters should be purchased from your provider.
5. Put the filter cap back.
   CAUTION Do not use cotton or any other material as a filter.
6. Do not wash or reuse the filter. Do not operate the unit without a filter.

Service
Except for the above-instructed maintenance, all device servicing must be performed by a Salter Labs® authorized service representative. There are no serviceable parts inside the unit. Contact your Salter Labs dealer or authorized service centre if your unit needs repair.
WARNING Do not tamper with or attempt to repair the device. Refer servicing to qualified service personnel.

Expected Service Life
The products are intended to offer safe and reliable operation when used or installed according to the instructions provided by Salter Labs. Salter Labs recommends that the system be inspected and serviced by authorized technicians if there are any signs of wear or concerns with device function and indication on products. Otherwise, service and inspection of the devices generally should not be required.

Troubleshooting

If your Salter AIRE Elite Compressor fails to function, consult the Troubleshooting guide below. If the problem persists, consult your equipment provider.

Problem	Cause and Solution
Device doesn’t operate	·      Check if plug is properly fit into an appropriate electrical outlet. ·      When device has been run continuously for over 30 minutes right before using, an auto shut down may activate by built-in thermal protector, cool down device for 30 minutes before next usage.
Weak Nebulization	·      Check for proper electrical voltage. ·      Check tubing for blockage or air leakage at connection to Salter AIRE Elite Compressor or nebulizer cup, replace as needed. ·      Check the nebulizer cup if it is properly assembled and not damaged. If there is any damage, replace as needed. ·      Check if filter is too dirty, replace as needed.

Specifications

(All specifications are subject to change without notice.)

Electrical Rating (Note: Refer to the rating label on the product)		120VAC,60Hz,1.2A (For 120V System)	230VAC, 50Hz, 0.6A (For 230V System)
Maximum Compressor Pressure		≧30 psi
Nebulizer Flow Rate		≧5.5 lpm	≧5.0 lpm
Classification		Class II. BF equipment. IP2X No AP/APG protection.
Applied part		Mouthpiece or Nasal mask
Dimensions (W x D x H)		14.6 × 20.3 × 9.5 cm / 5.7” × 7.9” × 3.7”
Weight (approx.)		1.8 kg / 4.0 lb
Fuse (non-user serviceable)		F5AL 250V	T1.6AL 250V
Expected Service Life		3 Years (minimum)
Warranty		5 Years
Environment	Temperature	Operation: 10℃ to 40℃/ 50℉ to 104℉
		Storage: -15℃ to 50℃ / 5℉ to 122℉            Transport: -15℃ to 70℃/ 5℉ to 158℉
	Humidity	Operation: 10% to 90%RH non-condensing
		Storage: 10% to 90%RH non-condensing
		Transport: 10% to 90% RH non-condensing
	Atmospheric Pressure	Operation: 700-1060 hPa

Accessories

Model Description
8501-1-2 Salter AIRE Elite Replacement filters
8258-0-1 Compressor Carrying bag
8660 NebuTech® Nebulizer – Reusable
8960 NebuTech Nebulizer – Disposable
8967 NebuTech Nebulizer with Pediatric Mask
8984 NebuTech Nebulizer with Adult Mask
8900 Nebulizer with Tee Adapter
8906 Nebulizer with Pediatric Mask
8924 Nebulizer with Adult Mask

Appendix A: EMC Information
Guidance and Manufacturer’s DeclarationElectromagnetic Emissions: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.

Emissions Test	Compliance	Electromagnetic Environment- Guidance
RF emissions CISPR 11	Group 1	The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment
RF emissions	Class B
CISPR 11
Harmonic emissions IEC61000-3-2	Class A	The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network.
Voltage fluctuations / Flicker emissions	Complies
IEC61000-3-3

Warning

1. The device should not be used adjacent to or stacked with other equipment.
2. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
3. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
4. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Compressor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Guidance and Manufacturer’s DeclarationElectromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.

Immunity Test	IEC60601 test level	Compliance	Electromagnetic Environment-Guidance
Electrostatic Discharge (ESD) IEC61000-4-2	±8kV contact ±15kV air	±8kV contact ±15kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material,

			the relative humidity should be at least 30%.
Electrical fast transient/ burst IEC61000-4-4	±2kV for power supply line ±1kV for input/out line	±2kV for power supply line ±1kV for input/out line	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC61000-4-5	± 1 kV line(s) to line(s) ± 2 kV line(s) to earth	± 1 kV line(s) to line(s)	Mains power quality should be that of a typical commercial or hospital environment.
	Voltage Dips: i) 100%	Voltage Dips: i) 100% reduction for 0.5 period, ii) 100% reduction for 1 period, iii) 30% reduction for 25/30 period, Voltage Interruptions: 100% reduction for 250/300 period	Mains power quality should be that of a
	reduction for		typical commercial or
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11	0.5 period, ii) 100% reduction for 1 period, iii) 30% reduction for 25/30 period, Voltage Interruptions: 100% reduction		hospital environment. If the user of this device requires continued operation during power mains interruptions, it is recommended that the device be powered from an
	for 250/300		uninterruptible power
	period		supply or a battery.
Power			Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
frequency
(50/60Hz) magnetic	30 A/m	30 A/m
field
IEC61000-4-8

Recommended separation distances between portable and mobile RF communications equipment and this device: This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power	Separation distance according to frequency of transmitter (m)
	150 kHz to 80 MHz d =  P	80 MHz to 800 MHz d = 0.6 P	800 MHz to 2,7 GHz d = 1.2 P
0.01	0.1	0.06	0.12
0.1	0.31	0.19	0.38
1	1	0.6	1.2
10	3.1	1.9	3.8
100	10	6	12

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.

Immunity Test	IEC60601 test level	Compliance	Electromagnetic Environment- Guidance
Conducte d RF IEC 61000- 4-6	3Vrms 150 kHz to 80 MHz 6Vrms ISM bandsa	3Vrms 150 kHz to 80 MHz 6Vrms ISM bandsa Between 150 kHz to 80 MHz 80% AM at 1kHZ   10 V/m 80 MHz to 2.7GHz 80% AM at 1kHZ 385-6000 MHz, 9- 28V/m, 80% AM (1kHz) pulse mode and other modulation	Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than there commended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d =  P 150 kHz to 80 MHz
Radiated RF IEC 61000- 4-3	Between 150 kHz to 80 MHz 80% AM at 1kHZ     10 V/m 80 MHz to 2.7GHz 80% AM at 1kHZ 385-6000 MHz, 9-28V/m, 80% AM (1kHz) pulse mode and other modulation		d = 0.6 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2,7GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency ranged.
			Interference may occur in the vicinity of equipment marked with the following

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a/ Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy.

To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b/ Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10/m.

Manufacturer’s declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The 9R-029003(8353-1) is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the 9R-029003(8353-1) should assure that it is used in such an environment.
Test frequency (MHz)	Band a) (MHz)	Service a)	Modulation b)	Maximum power (W)	Distance (m)	Immunity Test Level	Compliance Level (V/m) (for home
385	380 – 390	TETRA 400	Pulse modulati on b) 18 Hz	1,8	0,3	27	27
450	430 – 470	GMRS 460, FRS 460	FM c) ±5 kHz deviatio n 1 kHz sine	2	0,3	28	28
710	704 – 787	LTE Band 13, 17	Pulse modulati on b) 217 Hz	0,2	0,3	9	9
745
780
810	800 – 960	GSM 800/900,T ETRA 800, iDEN 820, CDMA 850, LTE Band 5	Pulse modulati on b) 18 Hz	2	0,3	28	28
870
930
1 720	1 700 – 1 990	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS	Pulse modulati on b) 217 Hz	2	0,3	28	28
1 845
1 970
2 450	2 400 – 2 570	Bluetooth , WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7	Pulse modulati on b) 217 Hz	2	0,3	28	28
5 240	5 100 – 5 800	WLAN 802.11 a/n	Pulse modulati on b) 217 Hz	0,2	0.3	9	9
5 500
5 785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a)     For some services, only the uplink frequencies are included. b)     The carrier shall be modulated using a 50 % duty cycle square wave signal. c)     As an alternative to FM modulation, 50% pulse modulation at 18Hz may be used because while it does not represent actual modulation, it would be worst case.

Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The 9R-029003(8353-1) is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the 9R-029003(8353-1) should ensure that it is used in such an environment.

EQUIPMENT or ME SYSTEM
may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

• For some services, only the uplink frequencies are included.
• The carrier shall be modulated using a 50 % duty cycle square wave signal.
• As an alternative to FM modulation, 50% pulse modulation at 18Hz may be used because while it does not represent actual modulation, it would be wothe rst case.

30 Spur Drive
El Paso, TX, 79906 USA
30 Spur Drive
El Paso, TX, 79906 USA
Phone: 1-800-421-0024, 1-800-235-4203
Toll-Free Fax: 1-800-628-4690
E-mail: customercare@salterlabs.com
www.salterlabs.com

Authorized Representative in the E.U.:
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert, Germany
NOTE Consult distributor(s) or EU representative(s)
for additional technical documents.

Download PDF: Salter Labs 8350-1 AIRE Elite Compressor Nebulizer User Manual

References

• User Manual